MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #1 RM/LL -10MM; IMPLANT

Catalog Number 5630-G-120

Device Problems Device Abrasion From Instrument Or Another Object (1387); Fitting Problem (2183); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2015

Event Type  malfunction  

Event Description

During a right primary pkr uni knee procedure, the surgeon was unable to fully seat the insert.A backup was immediately available and the surgery was completed successfully.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding difficulty seating a triathlon pkr insert into a baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: a functional inspection indicated the device is fully functional.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar reported events for this lot id.Conclusions: the reported event could not be replicated nor confirmed as the device was determined to be fully functional.It is likely the user attempted to implant the insert while misaligned with the baseplate.

Event Description

During a right primary pkr uni knee procedure, the surgeon was unable to fully seat the insert.A backup was immediately available and the surgery was completed successfully.

• Brand Name: TRIATHLON PKR INSERT X3 #1 RM/LL -10MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4795305
• MDR Text Key: 15355035
• Report Number: 0002249697-2015-01670
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 5630-G-120
• Device Lot Number: MLR1RJ
• Other Device ID Number: STERILE LOT# MSGLR19D6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR
• Patient Weight: 51